Decriminalisation (sort of) at last 

A new statutory defence came into force on 16 April, entitling pharmacy staff to be acquitted if they are prosecuted under section 64 of the Medicines Act 1968 because the wrong prescription medicine has been supplied and a patient is harmed.

The defence does not apply to over-the-counter medicines, and a defendant will only be acquitted by proving that certain conditions are met. Typically, these will be that the pharmacist did not know that the wrong medicine was being supplied, and that when the error was discovered, the patient was promptly notified.

Market entry review

The Department of Health and Social Care has published a review of the market entry regulations in England.

The review concludes that the regulations have "largely achieved" the original policy objectives of encouraging the supply of services without excessive provision in areas already meeting demand. However, the review recommends undertaking a consultation on possible amendments to address certain unintended consequences of the Regulations.

The issues that may give rise to future amendment to the Regulations include:

  • GPs directing prescriptions to distance selling pharmacies in which they have a commercial interest
  • streamlining the application process for "minor" relocations
  • relaxing restrictions on dispensing doctors so as to enable them to dispense from additional premises if they amalgamate with a non-dispensing practice
  • Allowing 100-hour pharmacies to reduce their hours if this is necessary in order to remain financially viable

Recent market entry decisions

Our recent market entry cases include:

  • Successfully opposing a combined change of ownership and relocation application in Birmingham.

The applicant wanted to purchase a contract at a pharmacy closed by Boots and relocate it about 600m to a site close to where a GP practice was due to relocate. NHS England had granted the application without giving any reasons. Our client's appeal was upheld because, amongst other things, patients with mobility issues could have difficulty accessing the proposed site where there was less car parking and limited public transport

  • Successfully opposing a new contract application in Blaenau Gwent, Wales

Premises standards

A new Premises Standards Order came into force on 24 May 2018. The Order:

  • gives the GPhC power to enforce premises standards through improvement notices rather than prosecution
  • gives the GPhC power to produce premises standards which will extend not only to registered premises but also to "associated" premises, and will take into account the "working environment"
  • gives the GPhC power to refer premises standards cases to the Fitness to Practise Committee
  • gives the Fitness to Practise Committee power to disqualify pharmacy owners and to remove premises from the register
  • gives the Fitness to Practise Committee power to impose an interim suspension pending a full hearing
  • gives the GPhC power to publish inspection reports

GPhC premises inspection consultation

Tied in with the new Premises Standards Order, the General Pharmaceutical Council has just launched a consultation on a new pharmacy inspection regime. The consultation, which is open until 9 August 2018, proposes, amongst other things:

  • Most future inspections would be unannounced
  • New inspection outcomes either `standards met' or `standards not all met'
  • Publishing inspection reports, and improvement action plans where relevant, on a new website

You can find a link to the consultation here.

Specials

The Times has been running a series of articles about the cost to the NHS of non-Drug Tariff specials. Possibly linked to this, the DHSC has announced that it is now finalising Regulations that are expected to come into force later in Summer 2018. These will ensure that the Government can require manufacturers to provide information about specials. To see David Reissner and Andrew Sweetman's Pharmaceutical Journal article on the Medical Costs Act, click here.

Sexual misconduct and fitness to practise 

In rejecting a doctor's appeal against striking off for two incidents on a single day, Mrs Justice Yip ruled in the High Court that there has been a shift in the attitude to and public perception of "low level" sexual offences, which were now "rightly regarded as being more serious than they once were".

Pharmacy student wins appeal against exclusion

In HA v- University of Wolverhampton, a pharmacy student obtained an order quashing a decision to exclude him from his undergraduate course.

The student had failed to disclose criminal convictions dating from when he was a juvenile. Mr Justice Julian Knowles found that the university's fitness to practise panel had failed to strike a fair balance between the student's rights and the protection of the public. Amongst other things, the panel had failed to take into account that different considerations may apply to convictions at a young age, and the panel also approached the question of sanction in a way that did not ensure proportionality.

Latest market entry data

The latest appeals data from NHS Resolution reveals that in 2017/18:

  • The number of successful unforeseen benefits applications rose slightly to 24%.
  • The number of successful relocation applications dropped to 55%
  • The number of successful distance selling applications rose to 51%

NHS England and Capita

The National Audit Office has produced a report that is highly critical of NHS England's outsourcing contract with Capita.

In relation to market entry, the NAO reported that even though the volume of applications was significantly lower than NHS England had anticipated:

  • Long delays in the new pharmacies being approved and changes in ownership of existing businesses being processed. Only 41% of applications were processed within 70 days in November 2017. In one case a pharmacist reported being unable to retire
  • NHS England believes that overall the service is being delivered to standard. However, it has concerns that the end-to-end process is taking too long in some cases, sometimes due to factors which it agrees are outside Capita's control
  • This Autumn, it is proposed to replace multiple application forms for market entry with a single online application